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Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels

NCT ID: NCT00852098

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-11-30

Study Completion Date

2008-05-31

Brief Summary

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Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.

Detailed Description

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Conditions

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Gastroesophageal Reflux

Keywords

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Fundoplication gastroesophageal reflux gastric vessels surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

dividing short gastric vessels

Group Type ACTIVE_COMPARATOR

Lap Nissen fundoplication with division of short gastric vessels

Intervention Type PROCEDURE

Dividing short gastric vessels

2

non-dividing short gastric vessels

Group Type ACTIVE_COMPARATOR

Laparoscopic Nissen fundoplication without division of short gastric vessels

Intervention Type PROCEDURE

non-dividing short gastric vessels

Interventions

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Lap Nissen fundoplication with division of short gastric vessels

Dividing short gastric vessels

Intervention Type PROCEDURE

Laparoscopic Nissen fundoplication without division of short gastric vessels

non-dividing short gastric vessels

Intervention Type PROCEDURE

Other Intervention Names

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Fundoplication, Gastroesophageal Reflux,Surgery Fundoplication, Gastroesophageal Reflux,Surgery

Eligibility Criteria

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Inclusion Criteria

* objective gastroesophageal reflux in adults

Exclusion Criteria

* esophageal motility disorder
* hard stenosis
* previous antireflux surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital State Public

UNKNOWN

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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FEDERAL UNIVERSITY OF SÃO PAULO

Principal Investigators

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José Carlos DelGrande, MD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Michelle L DeOliveira, MD

Role: STUDY_CHAIR

Federal University of São Paulo

Francisco Farah, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Renato Lupinacci, MD

Role: STUDY_CHAIR

Hospital State Public Server São Paulo

Locations

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Federal University of São Paulo - UNIFESP

São Paulo, São Paulo, Brazil

Site Status

State Public Server of São Paulo Hospital (HSPE)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG. Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg. 2008 Jan;247(1):38-42. doi: 10.1097/SLA.0b013e31814a693e.

Reference Type BACKGROUND
PMID: 18156921 (View on PubMed)

O'Boyle CJ, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Division of short gastric vessels at laparoscopic nissen fundoplication: a prospective double-blind randomized trial with 5-year follow-up. Ann Surg. 2002 Feb;235(2):165-70. doi: 10.1097/00000658-200202000-00001.

Reference Type BACKGROUND
PMID: 11807353 (View on PubMed)

Watson DI, Jamieson GG, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford G, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society for Diseases of the Esophagus--Australasian Section. Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004 Nov;139(11):1160-7. doi: 10.1001/archsurg.139.11.1160.

Reference Type BACKGROUND
PMID: 15545560 (View on PubMed)

Farah JF, Grande JC, Goldenberg A, Martinez JC, Lupinacci RA, Matone J. Randomized trial of total fundoplication and fundal mobilization with or without division of short gastric vessels: a short-term clinical evaluation. Acta Cir Bras. 2007 Nov-Dec;22(6):422-9. doi: 10.1590/s0102-86502007000600002.

Reference Type RESULT
PMID: 18235928 (View on PubMed)

Related Links

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http://www.umm.edu/general_surgery/nissen_fundo.htm

Related Info

Other Identifiers

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1069/06

Identifier Type: -

Identifier Source: org_study_id